US2008220029A1PendingUtilityA1

Fast-dissolving/disintegrating film preparation having high proportion of active

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Assignee: NG CHARLENEPriority: Mar 5, 2007Filed: Mar 5, 2007Published: Sep 11, 2008
Est. expiryMar 5, 2027(~0.6 yrs left)· nominal 20-yr term from priority
Inventors:Charlene Cheuk Ling NgSeema ModyJosh Ghaim
A61K 31/192A61K 31/616A61K 31/405A61K 47/36A61K 31/167A61K 31/09A61K 33/26A61K 9/0056A61K 9/7007A61K 47/34A61K 31/165A61K 9/70
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Claims

Abstract

The invention provides a fast-dissolving or fast-disintegrating film preparation having a high proportion (i.e., at least about 40%) of active agent(s) and related methods for its preparation. In one embodiment, the active agent is a pharmaceutical and the film comprises between about 10% and about 40% pullulan as a primary or sole water-soluble polymer.

Claims

exact text as granted — not AI-modified
1 . A fast-dissolving or fast-disintegrating film comprising:
 an active agent comprising at least about 40% of the film, by weight; and   at least one water-soluble polymer comprising between about 10% and about 40% of the film, by weight,   wherein the active agent is a poorly-water-soluble solid at room temperature.   
     
     
         2 . The film of  claim 1 , wherein the active agent includes at least one active selected from the group consisting of a pharmaceutical, a cosmetic agent, a vitamin, a mineral or a mixture thereof. 
     
     
         3 . The film of  claim 1 , wherein the active agent comprises between about 40% and about 90% of the film, by weight. 
     
     
         4 . The film of  claim 3 , wherein the active agent comprises between about 50% and about 80% of the film, by weight. 
     
     
         5 . The film of  claim 4 , wherein the active agent comprises between about 50% and about 70% of the film, by weight. 
     
     
         6 . The film of  claim 5 , wherein the active agent comprises between about 50% and about 60% of the film, by weight. 
     
     
         7 . The film of  claim 1 , wherein the at least one water-soluble polymer is selected from a group consisting of: pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, methylcellulose, polyvinylpyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, polyethylene oxide, tragacanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymers, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein and mixtures thereof. 
     
     
         8 . The film of  claim 1 , wherein the at least one water-soluble polymer comprises between about 10% and about 30% of the film, by weight. 
     
     
         9 . The film of  claim 8 , wherein the at least one water-soluble polymer comprises about 12% to about 18% of the film, by weight. 
     
     
         10 . The film of  claim 1 , wherein the film is orally-consumable. 
     
     
         11 . The film of  claim 10 , wherein the film is adapted to substantially dissolve or disassociate within an oral cavity within about 1 minute. 
     
     
         12 . The film of  claim 10 , further comprising an agent selected from the group consisting of a flavoring agent; a coloring agent and a mixture thereof. 
     
     
         13 . The film of  claim 1 , wherein the film is adapted for topical application. 
     
     
         14 . The film of  claim 1 , wherein the film is a multi-layer film. 
     
     
         15 . The film of  claim 1 , wherein the film is substantially free of modified starches. 
     
     
         16 . A fast-dissolving or fast-disintegrating film comprising:
 an active agent comprising at least about 40% of the film, by weight; and   pullulan as a sole or primary water-soluble polymer comprising between about 10% and about 40% of the film, by weight,   wherein the active agent is a poorly-water-soluble solid at room temperature.   
     
     
         17 . The film of  claim 16 , wherein the active agent is an active selected from the group consisting of a pharmaceutical, a vitamin, a mineral or mixtures thereof. 
     
     
         18 . The film of  claim 16 , wherein the active agent comprises between about 40% and about 90% of the film, by weight. 
     
     
         19 . The film of  claim 18 , wherein the active agent comprises between about 50% and about 80% of the film, by weight. 
     
     
         20 . The film of  claim 19 , wherein the active agent comprises between about 50% and about 70% of the film, by weight. 
     
     
         21 . The film of  claim 20 , wherein the active agent comprises between about 50% and about 60% of the film, by weight. 
     
     
         22 . The film of  claim 16 , wherein the pullulan comprises between about 12% and about 18% of the film, by weight. 
     
     
         23 . The film of  claim 22 , wherein the pullulan comprises about 15% of the film, by weight. 
     
     
         24 . The film of  claim 16 , wherein the film is orally-consumable. 
     
     
         25 . The film of  claim 24 , wherein the film is adapted to substantially dissolve or disassociate within an oral cavity within about 1 minute. 
     
     
         26 . The film of  claim 24 , further comprising an agent selected from the group consisting of a flavoring agent; a coloring agent and a mixture thereof. 
     
     
         27 . The film of  claim 16 , wherein the film is adapted for topical application. 
     
     
         28 . The film of  claim 16 , wherein the film is a multi-layer film. 
     
     
         29 . The film of  claim 16 , wherein the film is substantially free of modified starches. 
     
     
         30 . A method for preparing a fast-dissolving or fast-disintegrating film comprising a high dose of active agent, the method comprising the steps of:
 dissolving in a quantity of water or a quantity of water and an alcohol, a quantity of at least one water-soluble polymer comprising between about 10% and about 40% of the dry film, by weight;   adding to the resulting solution a quantity of at least one active agent comprising at least about 40% of the dry film, by weight;   casting the resulting suspension on a supporting substrate; and   drying the cast suspension to form a film.   
     
     
         31 . The method of  claim 30 , wherein the at least one water-soluble polymer is selected from a group consisting of: pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, methylcellulose, polyvinylpyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, polyethylene oxide, tragacanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymers, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein and mixtures thereof. 
     
     
         32 . The method of  claim 30 , wherein the at least one water-soluble polymer comprises between about 10% and about 30% of the film, by weight. 
     
     
         33 . The method of  claim 32 , wherein the at least one water-soluble polymer comprises about 15% of the film, by weight. 
     
     
         34 . The method of  claim 30 , wherein the at least one active agent is selected from a group consisting of: a pharmaceutical, a medicament, a drug, a therapeutic agent, a diagnostic agent, a cosmetic agent, a nutritional supplement and a mixture thereof. 
     
     
         35 . The method of  claim 30 , wherein the active agent comprises between about 40% and about 90% of the film, by weight. 
     
     
         36 . The method of  claim 35 , wherein the active agent comprises between about 50% and about 80% of the film, by weight. 
     
     
         37 . The method of  claim 36 , wherein the active agent comprises between about 50% and about 70% of the film, by weight. 
     
     
         38 . The method of  claim 37 , wherein the active agent comprises between about 50% and about 60% of the film, by weight. 
     
     
         39 . The method of  claim 30 , further comprising the step of:
 adding to at least one of the quantity of water, the resulting solution, and the resulting suspension, at least one of the following: a flavoring agent and a coloring agent.]   
     
     
         40 . The method of  claim 30 , further comprising the step of:
 cutting the dried film to a size sufficient to contain a desired dose of the active agent.   
     
     
         41 . The method of  claim 30 , wherein the film is adapted for at least one of the following: oral consumption and topical application.

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